DICOM and FDA - DICOM

This is a discussion on DICOM and FDA - DICOM ; Is there any guideline form the FDA which says that DICOM is the
preferred method of sending images to the agency for a submission? Do
they accept compressed images such as jpeg?...

DICOM and FDA

Is there any guideline form the FDA which says that DICOM is the
preferred method of sending images to the agency for a submission? Do
they accept compressed images such as jpeg?

Re: DICOM and FDA

jeffcoh@gmail.com wrote:
> Is there any guideline form the FDA which says that DICOM is the
> preferred method of sending images to the agency for a submission? Do
> they accept compressed images such as jpeg?

Submission for what purpose ?

David

Re: DICOM and FDA

jeffcoh@gmail.com wrote:
> Is there any guideline form the FDA which says that DICOM is the
> preferred method of sending images to the agency for a submission? Do
> they accept compressed images such as jpeg?

What kind of submission are you talking about? Typically what you see
on this forum are questions about getting FDA clearance for DICOM or
medical imaging devices to be used in clinical processes. Normally
submitting imaging data, DICOM or otherwise, would not be part of that
process.

For clinical drug trials, the data submission to the FDA would not
normally include the image data. Rather, it would include the
information such as measurements and conclusions extracted tests
performed during the clinical trial. There is a format called the Study
Tabulation Data Model (SDTM) which is currently being piloted for
submissions. SAS transport files and PDF files have also been formats
which the FDA has accepted for submission data. That said, the FDA has
indicated in recent years that they reserve the right to be able to
inspect any of the raw data which has been the input to extracting
clinical trial measurements. The submitter is expected to maintain the
"raw data" in the form in which it was received from the clinical trial
site. When imaging data has been the input, the submitter will very
often have received it in DICOM format and it will therefore be
provided to the FDA in DICOM format.

Another process which is ongoing. An organization called the clinical
data interchange standards consortium defines standards for clinical
trial submissions. SDTM is their creature (with contribution from the
FDA). The SDTM format includes a digital format for including ekg/ecg
data directly in the submission (and in a format which is different
from the dicom waveform). CDISC is currently working on a new domain
for the SDTM submission format. It will likely include aspects from the
DICOM data model, but at this point I wouldn't count on it "being"
DICOM.